TetraSens Pediatric SEN 2009

GUDID 07350012440114

TetraSens Pediatric electrode

Senzime AB (Publ.)

Block-monitoring peripheral nerve electrical stimulation system
Primary Device ID07350012440114
NIH Device Record Key50f3b8b8-7069-4d2e-b7c9-57ef7bf0e194
Commercial Distribution StatusIn Commercial Distribution
Brand NameTetraSens Pediatric
Version Model NumberSEN 2009 TetraSens Pediatric
Catalog NumberSEN 2009
Company DUNS559976316
Company NameSenzime AB (Publ.)
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone2399204288
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com
Phone800-213-1324
Emailinfo.us@senzime.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107350012440114 [Package]
Contains: 07350012440121
Package: Box [15 Units]
In Commercial Distribution
GS107350012440121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOIStimulator, Nerve, Peripheral, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-15
Device Publish Date2022-09-07

On-Brand Devices [TetraSens Pediatric]

07350012440114TetraSens Pediatric electrode
07350012440190TetraSens Pediatric EZConnect

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